Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000125224
Ethics application status
Not yet submitted
Date submitted
20/11/2008
Date registered
20/02/2009
Date last updated
20/02/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Topical use of immunosupressor,Tacrolimus, in desquamative gingivitis patients: an open trial.
Scientific title
Use of topical immunosupressant,Tacrolimus, in desquamative gingivitis patients: evaluation of effectiveness according to individual and disease characteristics.
Universal Trial Number (UTN)
Trial acronym
Immunosupressants and desquamative gingivitis
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Desquamative gingivitis 4001 0
Condition category
Condition code
Inflammatory and Immune System 4577 4577 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patient will be shaped to get a plate of silicon on top of the model study, after will be delivered promptly to the patient with a tube of medication with Tacrolimus 0.1% gel, the patient will be guided in making the application through the trays that have the gel in it and take position in the mouth for 5 minutes twice a day for 90 days.
Intervention code [1] 4067 0
Treatment: Drugs
Comparator / control treatment
No treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5097 0
Effectiveness or lack of effectiveness followed through a chart that identifies presence and intensity of clinical signs (like ulcers, vesicles and erithema). Pain and discomfort will be checked by means of a Visual analogue scale (VAS).
Timepoint [1] 5097 0
VAS prior to drug delivery, 45-day and at the end of the period (90 day).
Clinical follow-up: starting point and every 15 days up to the end of 90-day period.
Secondary outcome [1] 8566 0
The results and effectiveness of the medication will be evaluated according to the type of disease by the professional researcher to compare the photos, using the VAS scale and the patient's complaint
Timepoint [1] 8566 0
45 and 90 days after the starting point.

Eligibility
Key inclusion criteria
Patients exhibiting desquamative gingivitis with consent agreement.
There will be no exclusion by gender, age, or race, only if the patient is carrying a change of renal or hepatic
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
the patient with renal failure and / or liver

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 1392 0
Brazil
State/province [1] 1392 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 4191 0
Self funded/Unfunded
Name [1] 4191 0
Country [1] 4191 0
Brazil
Primary sponsor type
University
Name
University of Sao Paulo
Address
Lineu Prestes Av, 2227 - University City - São Paulo / SP
Country
Brazil
Secondary sponsor category [1] 3765 0
None
Name [1] 3765 0
Address [1] 3765 0
Country [1] 3765 0
Other collaborator category [1] 487 0
Hospital
Name [1] 487 0
General Hospital of Uniersity of Sao Paulo
Address [1] 487 0
Eneas de Carvalho Aguiar, 255 - Cerqueira Cesar - Sao Paulo/SP
Country [1] 487 0
Brazil

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6248 0
University of Sao Paulo, Dentistry School Ethics Committee
Ethics committee address [1] 6248 0
Lineu Prestes Av, 2227 - University City - Sao Paulo / SP
Ethics committee country [1] 6248 0
Brazil
Date submitted for ethics approval [1] 6248 0
01/12/2008
Approval date [1] 6248 0
Ethics approval number [1] 6248 0

Summary
Brief summary
The main purpose of this trial is to assess the therapeutic efficacy of tacrolimus, in topical use, to the symptomatic treatment of desquamative gingivitis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29149 0
Address 29149 0
Country 29149 0
Phone 29149 0
Fax 29149 0
Email 29149 0
Contact person for public queries
Name 12306 0
Anna Torrezani
Address 12306 0
Abel Seixas Street, 76 - Santo Amaro - São Paulo/SP
Country 12306 0
Brazil
Phone 12306 0
55-11-55226845
Fax 12306 0
Email 12306 0
[email protected]
Contact person for scientific queries
Name 3234 0
Dante Antonio Migliari
Address 3234 0
Lineu Prestes Av, 2227 - University City - São Paulo / SP
Country 3234 0
Brazil
Phone 3234 0
55-11-30917883
Fax 3234 0
Email 3234 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.